Actively Recruiting
pH1N1 Blinded Challenge Study
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-08
90
Participants Needed
2
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A/Arkansas/08/2020 (pH1N1). The study is designed to determine the optimal infectious dose of the pH1N1 challenge strain for use in future clinical trials evaluating influenza countermeasures. The study will enroll and challenge adult volunteers with the pH1N1 influenza virus challenge or sham inoculations. Given the adaptive design of this trial, the potential number of participants can vary. Depending on the pathway recommended by the PSRT and followed in the Trial Schema, the study population can range from around 30 to 99. The anticipated final sample size will be approximately 90 receiving pH1N1 challenge product plus and 6 persons receiving a sham inoculation. Participants will be pre-screened for health and for serological HAI antibody titers of \</1:40 against the challenge strain. Eligible participants will be enrolled sequentially into challenge cohorts and will be randomly assigned to receive a single dose of either sham inoculation or the interventional study product at a dose between 10\^6 to 10\^7 TCID50 (or 10\^5 TCID50 if needed). Dose titration will be conducted under an adaptive escalation schedule whereby dosing will start at 10\^6 TCID50 and escalate to the next dose if a pre-determined symptomatic influenza attack rate and clinical symptom score thresholds are not met and if the dose is determined to be safe with no pre-defined halting criteria being met. The primary objectives of this study are to determine the optimal infectious dose of a pH1N1 viral challenge to cause laboratory-confirmed clinical influenza and to assess the safety profile of pH1N1 viral challenge.
CONDITIONS
Official Title
pH1N1 Blinded Challenge Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provides signed and dated informed consent before starting any trial procedures.
- Able to understand and agree to follow all trial procedures and attend all study visits.
- Age 18 to 55 years at enrollment.
- Agree to blood and nasal sample collection and participation in a biorepository protocol.
- In good general health with stable medical conditions for at least 90 days.
- Able to take oral medication and willing to receive study antiviral treatments.
- Participants of childbearing potential agree to use acceptable contraception starting 30 days before enrollment through study completion.
- Non-smoker or non-habitual smoker (no more than four cigarettes or similar products per week).
- No history of alcoholism in the past 2 years.
- No history of illicit drug use in the past 30 days.
- Agree not to use specified prescription or over-the-counter medications within 7 days before and during confinement unless approved.
- Screening pulse between 55 and 100 beats per minute.
- Screening systolic blood pressure between 90 and 140 mmHg.
- Screening diastolic blood pressure between 55 and 90 mmHg.
- Screening oxygen saturation (SpO2) at least 95 percent.
- Screening respiratory rate 16 or fewer breaths per minute.
- Screening oral temperature below 100.4 degrees Fahrenheit.
- Screening body mass index between 18.5 and less than 40 kg/m2.
- Screening laboratory tests within acceptable ranges.
- Negative tests for hepatitis B surface antigen, hepatitis C antibody (with conditions), and HIV antibodies.
- Normal or non-significant screening ECG and chest X-ray.
- Negative respiratory virus panel including influenza A and B and SARS-CoV-2 on days -2 and -1.
- Agree to remain in confinement for at least 6 days after enrollment and until discharge criteria are met.
- Agree to adhere to lifestyle requirements during the study.
You will not qualify if you...
- History of medical or psychiatric conditions that could affect participant safety or study results, including respiratory diseases requiring daily treatment, significant heart disease, neurological disorders, or immunodeficiency.
- Positive antibody titer greater than 1:40 against the influenza A/Arkansas/08/2020 (pH1N1) strain.
- Use of immunosuppressive medications or systemic corticosteroids above specified doses before screening.
- Current pregnancy or lactation.
- Presence of implanted cardiac devices.
- Recent blood or blood product transfusions or planned donations during the study.
- History of severe allergic reactions to drugs or biologics.
- Allergies to influenza treatments or multiple antibiotic classes.
- Allergy to components of the challenge virus inoculum.
- Febrile illness or respiratory infection symptoms at enrollment or early study days.
- Close contact with persons with respiratory viral illness within 7 days before enrollment.
- Current or planned enrollment in other investigational studies during this study period.
- Receipt of any live vaccine within 4 weeks before enrollment.
- Receipt or planned receipt of influenza vaccine within 4 months before or during the study.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States, 21201-1509
Actively Recruiting
2
Duke Vaccine and Trials Unit
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
M
Meagan Deming
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
12
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